Clinical Trial Results:
A randomised, double–blind, crossover efficacy and safety comparison of Tiotropium/Salmeterol (7.5 µg/ 25 µg) Inhalation Powder in the morning (PE Capsule via tiotropium/salmeterol HandiHaler®), Tiotropium (18 µg) Inhalation Powder in the morning (gelatine capsule via Spiriva® HandiHaler®), Salmeterol (50 µg) Multi-Dose Powder Inhaler in the morning and evening and the free combination Tiotropium (18 µg) Inhalation Powder in the morning (gelatine capsule via Spiriva® HandiHaler®) plus Salmeterol (50 µg) Multi-Dose Powder Inhaler in the morning and evening following chronic administration (6-week treatment periods) in patients with COPD
Summary
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EudraCT number |
2007-005135-28 |
Trial protocol |
DE |
Global completion date |
22 Jul 2009
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Mar 2016
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First version publication date |
09 Mar 2016
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Other versions |
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Summary report(s) |
Trial Synopsis |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.